Director Of Bioanalytical Development

Position Overview

This role will lead bioanalytical assay development to support pharmacokinetics (PK) and oligonucleotide‑based therapeutic programs across the drug discovery and development lifecycle. The position requires deep technical expertise in bioanalytical method development, regulatory compliance, and cross-functional collaboration to enable nonclinical and clinical development activities.

Key Responsibilities

• Lead bioanalytical development activities for pharmacokinetics and oligonucleotide therapeutics, including siRNA and conjugated ONTs.
• Design, optimize, and validate high‑sensitivity analytical methodologies such as LC‑MS/MS, hybrid ELISA, and qPCR for oligonucleotides and their metabolites across diverse biological matrices.
• Develop, optimize, and validate ligand‑binding assays (e.g., ELISA, MSD ECL) to support large‑molecule PK and immunogenicity assessments.
• Oversee full assay lifecycle management from early discovery through clinical registration, adapting methodologies to evolving program needs.
• Analyze, interpret, and report complex PK and immunogenicity data to support in vitro and in vivo ADME, DMPK, TK, and PK/PD evaluations.
• Ensure bioanalytical activities comply with global regulatory expectations, including ICH M10, and support IND and NDA submissions.
• Serve as a scientific leader, guiding CROs and internal teams across nonclinical, translational, and clinical development efforts.

Required Skills & Expertise

• PK bioanalytical assay development and validation
• DMPK, ADME, immunogenicity, and translational science
• Oligonucleotide therapeutics (siRNA, conjugated ONTs)
• LC‑MS/MS, qPCR, ELISA, MSD ECL, ligand‑binding assays
• Tissue and biofluid sample preparation and extraction
• CRO oversight and cross‑functional collaboration
• Regulatory bioanalysis supporting IND filings

Qualifications

• Ph.D. in Medicinal Chemistry, Analytical Chemistry, Biochemistry, or a related scientific discipline.
• Minimum of 7 years of hands‑on PK bioanalytical development experience within the biotech or pharmaceutical industry, including ADA assay experience.
• Proven success developing bioanalytical methods for oligonucleotides, including extraction techniques for tissue and biological matrices.
• Demonstrated leadership across drug discovery and development, encompassing in vitro/in vivo pharmacology, ADME, PK/PD, translational, and clinical research.

If interested, please reach out directly to Lindsee Allienello lallienello @ actalentservices.com

This is a Contract position based out of Bedford, MA.

The pay range for this position is $105.00 - $115.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Bedford,MA.

This position is anticipated to close on May 13, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $105 - $115